Our physician office business for medical and laboratory products is now part of Henry Schein Medical — the world’s largest provider of health care products and services for office-based medical, dental, and animal health practitioners.

FDA Expedited Programs

Accelerate drug development and approval for products that address unmet medical needs or provide significant improvement over available therapies

Whether you’re seeking fast track designation, breakthrough therapy designation, accelerated approval pathway, priority review designation or a combination of the four expedited programs, our experts
can provide the guidance needed to help you receive the full benefits of these programs. In addition, we will provide support for your regulatory documentation preparation and negotiations with the FDA. Cardinal Health Specialty Solutions provides regulatory consulting services that help clients successfully apply for and utilize the FDA expedited programs.

Benefits of the FDA expedited programs

The FDA developed the expedited programs to reduce the time spent on the development and review processes and provide a faster way to market for products that treat serious or life-threatening conditions. Each of these programs provides a different approach for expediting these complex regulatory processes.

Facilitates the development and expedited review of a drug intended to treat a serious condition for which nonclinical and clinical data demonstrate the potential to address an unmet medical need or a drug that has been designated as a qualified infectious disease product.

Shortens the development and review time when preliminary clinical evidence indicates that a new potential therapy may show substantial improvement on clinically significant endpoints over available therapies for a serious condition.